{"analyses":[{"ciLowerLimit":"0.56","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.45","estimateComment":"Based on Cox regression model with treatment as a covariate stratified by Age (\\<75 years vs \\>= 75 years) and ISS stage (I or II vs. III).","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.33475","paramType":"Hazard Ratio (HR)","paramValue":"0.90","statisticalComment":"One-sided p-value based on Stratified log-rank test.","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"comment":"Upper Limit could not be estimated due to an insufficient number of events by the date of data cutoff.","groupId":"OG000","lowerLimit":"15.3","upperLimit":"NA","value":"19.6"},{"comment":"The Median was not reached, and the Upper Limit could not be estimated due to insufficient number of events by the date of data cutoff.","groupId":"OG001","lowerLimit":"15.5","upperLimit":"NA","value":"NA"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"156"},{"groupId":"OG001","value":"154"}],"units":"Participants"}],"description":"PFS was defined as the time from randomization to the first documented disease progression (events of new bone lesions, soft tissue plasmacytomas or an increase in existing lesions, or death due to any cause). The median PFS was calculated from the product-limit (Kaplan-Meier) method for censored data. Due to the small number of events, the tail of the estimated survival distribution was close to the median for both arms. The higher variability of the tail estimates resulted in observing the median estimate in the experimental arm but not in the standard of care arm even when number of events in 2 arms were similar. The database cutoff date was July 9, 2018.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle PLUS lenalidomide 25 mg orally (PO) on Days 1 to 21 of each 21-day treatment cycle, and dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle for up to 18 cycles.","id":"OG000","title":"Pembrolizumab + Lenalidomide + Dexamethasone"},{"description":"Participants received lenalidomide 25 mg PO on Days 1 to 21 of each 21-day treatment cycle, and dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle for up to 18 cycles.","id":"OG001","title":"Lenolidomide + Dexamethasone"}],"paramType":"MEDIAN","populationDescription":"The analysis population included all randomized participants. Participants were included in the treatment group to which they were randomized.","reportingStatus":"POSTED","timeFrame":"Up to approximately 30 months","title":"Progression Free Survival (PFS) Evaluated According to the International Myeloma Working Group (IMWG) Response Criteria 2011 by Clinical Adjudication Committee (CAC) Blinded Central Review","type":"PRIMARY","unitOfMeasure":"Months"}